Full-Time

Quality Engineer II

Confirmed live in the last 24 hours

Penumbra Inc

Penumbra Inc

1,001-5,000 employees

Develops medical devices for vascular conditions

Biotechnology
Healthcare

Compensation Overview

$86.3k - $113.7kAnnually

Junior, Mid

Roseville, CA, USA

This position is onsite in Roseville, CA.

Category
QA & Testing
Manual Testing
Quality Assurance
Requirements
  • 2+ years experience in a manufacturing or laboratory environment required; medical device experience preferred; injection molding & tooling development preferred
  • A Bachelor’s or Master's degree in an engineering or scientific discipline required
  • Clear and concise written and oral communication skills preferred
Responsibilities
  • Experience on production lines manufacturing high performing catheter products
  • Provide valuable input in the design control process and help in developing and launching new products
  • Independently provide knowledge of Penumbra Quality Management System as it pertains to sustaining manufacturing operations as well as dealing with supplier quality and developing new products
  • Identify and drive areas of opportunity for process improvement, yield improvement, and cycle time reduction
  • Lead strategic plans for biocompatibility and sterilization for upcoming products
  • Determine root-cause of in-process quality assurance issues
  • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
  • Ensure other members of the department follow the QMS, regulations, standards and procedures.
  • Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects.

Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed to assist healthcare professionals in addressing issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses on a specific range of conditions and invests heavily in research and development to continuously enhance their offerings. The company's goal is to deliver high-quality medical devices that meet the needs of healthcare providers and improve patient outcomes.

Company Stage

IPO

Total Funding

$116.7K

Headquarters

Alameda, California

Founded

2004

Growth & Insights
Headcount

6 month growth

4%

1 year growth

11%

2 year growth

20%
Simplify Jobs

Simplify's Take

What believers are saying

  • Penumbra's recent product launches, such as the BMX81 and BMX96 in Europe, demonstrate their commitment to expanding and improving their product portfolio.
  • Significant investments from firms like Jennison Associates LLC and Algert Global LLC indicate strong financial backing and confidence in Penumbra's growth potential.
  • The company's participation in high-profile conferences like the Truist Securities MedTech Conference and the William Blair Growth Stock Conference highlights its industry recognition and thought leadership.

What critics are saying

  • The highly competitive medical device market requires Penumbra to continuously innovate to maintain its market position.
  • Regulatory challenges and the need for CE Marks and FDA approvals can delay product launches and impact revenue.

What makes Penumbra Inc unique

  • Penumbra's focus on both neurovascular and peripheral vascular conditions sets it apart from competitors who may specialize in only one area.
  • Their continuous investment in R&D ensures that they remain at the forefront of medical device innovation, particularly with recent launches like the Lightning Flash 2.0 CAVT technology.
  • Penumbra's global reach, serving healthcare providers in over 100 countries, provides a broad market presence that many competitors lack.

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